Regulatory Affairs – CDSCO Vacancies at Corpseed
Position: Regulatory Affairs – CDSCO
Organization: Corpseed
Location: Noida, Uttar Pradesh
Experience Level: Entry to Mid-Level
Employment Type: Full-Time
Job Overview
Corpseed, a renowned company in regulatory compliance, is currently seeking a Regulatory Affairs professional for their Noida office. This role focuses on managing compliance for medical devices and pharmaceuticals under the Central Drugs Standard Control Organization (CDSCO) guidelines. If you have experience in regulatory submissions, technical documentation, and handling queries related to CDSCO, this role is for you.
Key Responsibilities
As part of the Regulatory Affairs team at Corpseed, your main duties will include:
1. CDSCO Registration
- Oversee and manage the registration process for medical devices and drugs under CDSCO regulations.
- Ensure compliance with all legal and procedural standards set by the CDSCO.
2. Regulatory Submissions
- Draft, review, and submit all necessary documents for regulatory approvals.
- Address queries, corrections, and post-registration follow-ups.
3. Government Portal Applications
- Submit regulatory documents through online government portals like CDSCO and others.
4. Medical Device Rules 2017
- Ensure strict compliance with Medical Device Rules 2017 and ISO standards for medical devices.
5. BIS, BEE, and FDA Registrations
- Handle processes related to Bureau of Indian Standards (BIS), Bureau of Energy Efficiency (BEE) registration, FDA approvals, and similar certifications.
6. Technical Documentation
- Review technical documents related to CDSCO compliance, including Legal Metrology registration, Pollution NoC, and waste management compliance.
7. Query Handling
- Respond to client queries on CDSCO registration requirements for medical devices, drugs, and cosmetics.
Qualifications and Skills
Educational Background:
- B.Pharm, M.Pharm, Pharm.D, MSc, BSc, or degrees in Life Sciences or Biomedical Engineering.
Experience:
- 1 to 2 years of experience in Regulatory Affairs related to medical devices or pharmaceuticals.
Key Skills:
- Expertise in CDSCO regulations and online submission procedures.
- Knowledge of Medical Device Rules 2017.
- Strong documentation skills and ability to handle technical regulatory queries.
Salary and Benefits
While the exact salary is not disclosed, Corpseed offers a competitive compensation package and an opportunity to work in a growing field with immense career prospects.
How to Apply
Interested candidates should submit their resumes to nitisha.kumari@corpseed.com with the subject line “Regulatory Affairs – CDSCO Application.” Be sure to highlight your experience in regulatory compliance, particularly with CDSCO regulations and medical device rules.
Application Process
The selection process will involve an initial resume screening, followed by interviews to assess technical expertise, particularly in the CDSCO framework.
Why Choose Corpseed?
Corpseed is a leading name in regulatory compliance, particularly in medical devices and pharmaceuticals. Joining Corpseed provides you with:
- Exposure to cutting-edge compliance processes.
- An opportunity to work with top experts in the regulatory field.
- Career growth in a thriving sector.
For more information, visit Corpseed’s website.
Important Links
- Learn more about Regulatory Affairs
- Know about CDSCO
- Read about Medical Device Rules
Apply Today and take your career in regulatory affairs to the next level!